Write-up: Information has been received from a physician concerning a 21 year old female with no history of drug reactions/allergies, and a history of idiopathic thrombocytopenic purpura who on 9/25/06 was vaccinated IM with HPV vaccine (Lot 653735/0688F). There was no concomitant medications. In Sept 2006, a few days after vaccination the pt experienced a headache, nose bleed and developed thrombocytopenia. The pts platelet count on an unspecified date was 43,000. The pt was hospitalized and received platelet transfusion. A CT of the head and lumbar puncture were performed, however the results were unspecified. The pt subsequently recovered on an unspecified date. The reporting physician felt that one or more of the events was an other important medical event (OMIC) and life threatening. Additional Information has been requested.

Write-up: Seriousness criteria other medically significant (OMIC). Initial report received on 05 December 2006 from a health care professional. A three year old male patient, with no pre existing medical history, had received an intramuscular, left thigh injection of Fluzone, lot number U2239AA, on 03 November 2006. He had previously received four doses of influenza vaccine with no reported adverse effect. Other medications included Claritin as needed. Two weeks post vaccination, the patient developed bruising. Seventeen days later, laboratory testing showed a decreased platelet count of 19,000. The patient was diagnosed with idiopathic thrombocytopenic purpura. At the time of this report, the patient had not recovered. Additional medically relevant information was not provided.

Write-up: MMR-V Proquad is given on 10/4/06 with Hib. After one month, he developed thromboycytopenia treated for idiopathic thrombocytopenia purpura. Due to persisted thrombocytopenia most likely reason is vaccine associated thrombocytopenia. 02/06/2007: MR received from 2 hospital admissions for easy bruising related to low platelets which had been occuring for approximately 2 weeks. No epistaxis or other bleeding noted. Sent to ER from Pediatrician''s office where platelet count was found to be 7000. He was admitted and treated with Rhogam. Two weeks later he was re-admitted for increased bruising again and treated with IgG. PE: WNL except multiple areas of ecchymosis of lower extremities, chest, forearms, and face on both admissions. Petechia noted on face, arms, legs, and buttocks on 11/16/06. Discharge DX on 11/18/2006: Idiopathic thrombocytopenic purpura. Discharge DX on 11/29/2006: 1) Thrombocytopenia IgG 2) Anemia. 02/19/2007: MR received from PCP. Infant in for 1 yr. check-up on 10/04/2006 with c/o sores in mouth and recurrent rash x several days. Fever for 2 days noted, now doing well. Child with DX: of Herpangina given Proquad and Pedvax. Seen again 10/25/2006 for cold sx. and conjunctivitis. Several hospital F/Us for ITP with repeated labs. DX: ITP.

Write-up: In September my daughter started getting bruises on her arms and legs. Everytime we asked how she got them she would reply that she bumped into a table or something. Having 4 children bruising is not so strange. She is in Martial Arts and has contact in class. This started out less obvious and little by little got more obvious. By October I noticed one day that she had major bruises on her arms and I immediately called her Doctor but after talking to him and he telling me to bring her in to get blood work I realized that she had participated in a Martial Arts tournament and went up against a 3rd degree black belt and felt that is where she recieved the bruises so I called the Doctor back and he told me to watch them. Well after a week went by I noticed that she had more bruises and they were really getting bigger. I then called him and he told me to come in for blood work. I took her in on Nov 5th and they sent me to the hospital to get the bloodwork done but when I got to the hospital they had left for the day so I returned the next morning. I got a call later that the blood work did not turn out to bring her in again which I did before I could get home they called and had me bring her back in due to her plateletes being at a critical level 7000 and this has been going on every since and they are calling it ITP. Now although the Doctor really does not believe that the vaccination was the start of this disorder I believe whole heartly it is He kept asking me if she had gotten any kind of virus in the month of August I kept repeating no. My daughter is now in the 6th grade and has never missed a day of school in her life that is how much she gets virus''s or sick. I know my children and I can count on one hand how many times this one has ever gotten anything and with my records at the pediatrician I do take my children to the doctor or call him when they are sick. My daughter has been on prednisone twice and Win Rho twice the first Iv medication only lasted about two weeks her plateletes continue to drop to a critical level. 02/07/07-records received and reviewed from PCP for DOS 11/10/06-2/5/07 DX: ITP Symptoms bruising. 02/13/07-records reviewed from hem/onc for DOS 02/01/07 DX: relapsing and remitting thrombocytopenia. Possibly since early September but documentation until early November. Looks like she is heading to have chronic IPT. Persistent low platelet counts. Bruising began in early September 2006, did not seek medical attention until first week in November. 11/8/06- platelets 7000 and on 11/10, 122000 and then on 11/10 79000. Child involved with martial arts. Began steroids. Hospitalized on 1/13 received WinRho at that time platelets 9000. Two nosebleed in November. PE:WNL except for some petechiae on neck. Per 60 day follow up: Bruising, petechiae, low platelets, ITP. The brusiing started at the begining of Sept. 2006, we did not get a diagnosis immediately due to not knowing anything. It is now considered chronic with no cure. She has been hospitalized on several occassions due to platelets dropping to a critical count.

Write-up: Information has been received from a physician at health conference, concerning her 15 year old daughter with a history of bleeding gums (attributed to orthodontic braces) previous 7 days, menstruation heavier 7 days earlier, slight sore throat approximately 1 week prior, and infectious mononucleosis showed possible acute infection, but seroconversion did not occur until 05-FEB-2007, possibly delayed by prolonged steroid treatment. On 03-OCT-2006, the patient was vaccinated with first dose of HPV vaccine. No reaction occurred. On 24-NOV-2006, the patient was vaccinated with second dose of HPV vaccine (lot # not reported), one month after the first dose. No reaction occurred. On 12-DEC-2006, poliovirus vaccine boosterix injection was given. A 5cm bruise developed within 4 hours. On 12-DEC-2006, the patient was hospitalized with a platelet count greater than 5. Signs included: 4 cm hematoma at the site of immunization left upper arm, few petechiae on lower abdomen, no hepato-splenomegaly. Provisional diagnosis of immune thrombocytopenia (ITP) was made. The patient was treated with Prednisone 75 mg stat, 3 weeks of 50 mg Prednisone, followed by decreasing dose over the next month. By 29-JAN-2007, the patient''s platelet count slowly returned to normal. The physician commented: "This is case of ITP, probably due to infectious mononucleosis, but diagnosed 18 days after the second dose of HPV vaccine (symptoms started approximately 10 days after the vaccine). I am hopeful it was due to Glandular fever but an interesting co-incidence and an unusual presentation of "IW." Additional information has been requested.